Brazil

Executive summary

Brazil is Latin America's largest pharmaceutical market and is regulated by the Agência Nacional de Vigilância Sanitária (ANVISA), an autonomous agency under the Ministry of Health created in 1999 (Law 9.782/1999). ANVISA regulates medicines, biologics, IVDs, devices, cosmetics, food, sanitisers, and tobacco. It joined ICH as a regulatory member in 2016 and PIC/S in 2021. ANVISA's defining 2017 reform — RDC 204/2017 (priority procedure) and RDC 205/2017 (Optimised Analysis based on prior decisions of AREE — Authorities Equivalent to Foreign Regulators) — created Brazil's first formal reliance pathway, accepting prior decisions from FDA, EMA, MHRA, Health Canada, TGA, and PMDA. RDC 884/2024 further reformed registration with shorter timelines (365 days for standard, 120 days for priority/AREE-based reliance). Pricing is regulated by the Câmara de Regulação do Mercado de Medicamentos (CMED), with ceiling prices set by international reference pricing across nine countries. Public reimbursement via SUS (Sistema Único de Saúde) requires CONITEC (HTA body) recommendation. Brazil also enforces extensive local content rules (PDP — Productive Development Partnerships) for public procurement.